<?xml version="1.0" encoding="UTF-8"?>
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    <udiDi>06950996003841</udiDi>
    <basicUdiDi>69509960FKTSH-402a-DRH9</basicUdiDi>
    <tradeName>TSH Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName>TSH Quantitative Test Kit (Time-Resolved FIA)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKTSH-402a-DR10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:48:59.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996003858</udiDi>
    <basicUdiDi>69509960FKTSH-402a-DRH9</basicUdiDi>
    <tradeName>TSH Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKTSH-402a-DR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:47:22.248Z</lastUpdated>
  </row>
  <row>
    <udiDi>06950996013130</udiDi>
    <basicUdiDi>69509960FKTSH-402a-DRH9</basicUdiDi>
    <tradeName>TSH Quantitative Test Kit (Time-Resolved FIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKTSH-402a-DRHG</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:47:21.744Z</lastUpdated>
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